SCALE KIDS: Research Study to Look at How Well a New Medicine is at Lowering Weight in Children With Obesity

Novo Nordisk

Status and phase: Active, not recruiting; Phase 3

Conditions: Obesity

Treatments: Drug: Liraglutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04775082

2020-000546-34 (Registry Identifier)

NN8022-4392

U1111-1247-8226 (Other Identifier)

Details and patient eligibility

About

The study looks at how liraglutide works on participant's body weight. Researchers will look at how liraglutide can help children with obesity to lose weight. They will look at how much weight the children will lose, and if there are any side effects.

Participants will either get liraglutide or placebo. Which treatment the participants get is decided by chance. Liraglutide is a new medicine for children, but it can already be prescribed by doctors to adults with overweight or obesity. The participant will get 1 injection every day.

In addition to taking the medicine, the participants will have talks with the study staff about healthy food choices, how they can be more physically active and what can be done to help the participants to lose weight.

The study will last for about 96 weeks (almost 2 years). The participants will have 18 clinic visits and 10 phone or video calls with the study doctor/staff. Participant will have blood samples taken, have 1 test to check the heart, 1 hand X-ray taken and must fill in a diary between some of the visits.

Enrollment: 78 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent of parent(s) or legally acceptable representative of subject and child assent, as age-appropriate, obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
• Male or female, aged 6 to below 12 years at the time of signing informed consent
• Tanner stage 1-5 pubertal development at the time of signing informed consent
• BMI above or equal to 95th percentile, on gender and age-specific growth charts (CDC.gov)
• History of failing to lose sufficient weight with lifestyle modification as judged by the investigator

For subjects with type 2 diabetes at screening the following inclusion criterion apply in addition:

• Hemoglobin A1c (HbA1c) below or equal to 10.0 percent (86 mmol/mol) as measured by central laboratory at screening

Exclusion criteria

• A self-reported (or by parent(s)/LAR (legally acceptable representative) where applicable) change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records
• Treatment with any medication for the indication of obesity within the past 90 days before screening
• Type 1 diabetes
• Subjects with secondary causes of obesity (for example hypothalamic, monogenic or endocrine causes)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 2 patient groups, including a placebo group

Liraglutide 3.0 mg

Experimental group

Description:

The treatment duration is 56 weeks and the follow-up period is 26 weeks.

Treatment:

Drug: Liraglutide

Placebo

Placebo Comparator group

Description:

The treatment duration is 56 weeks and the follow-up period is 26 weeks.

Treatment:

Drug: Placebo